Automated heart valve sewing

ABSTRACT

A system that can be used for suturing implants includes a first automated fixture that can comprise an articulation arm and a target device holder and a second automated fixture configured to operate as a sewing machine to sew material onto the implant. The second automated fixture uses a curved needle to form a stitch without having to release the needle in the process. The second automated fixture can also include a stitch looper that moves in coordination with the curved needle to perform a single-suture or single-thread stitch.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/938,879 filed Jul. 24, 2020 and entitled “AUTOMATED HEART VALVESEWING,” which is a national stage entry of PCT App. No.PCT/US2019/013340 filed Jan. 11, 2019 and entitled “AUTOMATED HEARTVALVE SEWING,” which claims priority from U.S. Provisional PatentApplication No. 62/617,114 filed Jan. 12, 2018 and entitled “AUTOMATEDHEART VALVE SEWING,” which is incorporated herein by reference.

BACKGROUND

Medical devices, prosthetic implants, prosthetic heart valves, etc. canrequire sewing, treatment, inspection, etc. of certain portions and/orcomponents thereof. Accuracy and/or efficiency in execution of suturingor other operations for such devices can be important. Furthermore,certain heart valve suturing operations or other operations can be timeconsuming and difficult.

SUMMARY

This summary is meant to provide some examples and is not intended to belimiting of the scope of the invention in any way. For example, anyfeature included in an example of this summary is not required by theclaims, unless the claims explicitly recite the features. Also, thefeatures, steps, concepts, etc. described in examples in this summaryand elsewhere in this disclosure can be combined in a variety of ways.The description herein relates to devices, apparatuses, systems,assemblies, methods, combinations, etc. that can be utilized formanufacturing and processing heart valves and/or associated or relatedcomponents, devices, apparatuses, etc. Among other features, these orelements of these can utilize or include logic that may receive a set ofparameters as input that may be graphically displayed, and/or may beanalyzed and new data generated and/or graphically displayed, to a userafter the parameters have been received as input.

In some implementations, the present disclosure relates to a method ofmanufacturing a target device or component, for example, to a method ofmanufacturing, or suturing, a prosthetic implant device (e.g., aprosthetic human implant device, prosthetic heart valve, prosthetichuman heart valve, etc.). The method comprises directing (e.g.,providing input, programming, running a program, pushing a button,clicking an icon, etc. to cause) the automated fixture to position thetarget device (e.g., prosthetic implant device, etc.) in a firstposition, executing a first operation or procedure on the target device,directing (e.g., providing input, programming, running a program,pushing a button, clicking an icon, etc. to cause) the automated fixtureto position the target device in a second position, and executing asecond operation or procedure on the target device. The method cancomprise disposing the target device on a holder component.

The method can also comprise using a needle and a stitch looper to forma stitch on the target device such that a stitch is formed without theneedle releasing the suture or thread. The needle can be a curved needlethat moves in a reciprocating fashion in conjunction with the stitchlooper that moves in a reciprocating fashion in coordination with thecurved needle to form the stitches on the target device.

In some implementations, a method of suturing an implant devicecomprises disposing the target or implant device (e.g., a prostheticheart valve, etc.) on a holder component of a first automated fixtureand directing (e.g., providing input, programming, running a program,pushing a button, clicking an icon, etc. to cause) the first automatedfixture to position the target or implant device in a first position.

In some implementations, the method also includes directing (e.g.,providing input, programming, running a program, pushing a button,clicking an icon, etc. to cause) a second automated fixture to execute afirst stitch on the implant device by passing a curved needle into andout of a material being sutured to the target or implant device.

The method can also comprise directing (e.g., providing input,programming, running a program, pushing a button, clicking an icon, etc.to cause) the first automated fixture to position the target or implantdevice in a second position (and, optionally, a third, fourth, fifth,and/or further additional positions).

In some embodiments, the method also includes directing (e.g., providinginput, programming, running a program, pushing a button, clicking anicon, etc. to cause) the second automated fixture to execute a secondstitch on the implant device by passing the curved needle into and outof the material being sutured to the target or implant device.

The second automated fixture can include a stitch looper that moves incoordination with the curved needle to form the first and secondstitches.

The method can also comprise directing the first automated fixture tocircumferentially rotate the implant device in place.

In some embodiments, the method comprises loading a pre-programmedsuturing procedure script using one or more processors configured tocontrol the first automated fixture and the second automated fixture.

The second automated fixture can use the curved needle to execute thefirst stitch such that the first stitch is a single suture stitch. Thecurved needle can be configured to pass into and out of the materialalong a fixed path of the curved needle. The curved needle can passthrough the material at two different locations for each of the firststitch and the second stitch.

The stitch looper can include two or more tines to secure a portion ofthe suture as the curved needle is withdrawn through insertion pointsformed during formation of the first stitch. The stitch looper can beconfigured to rotate to form a loop with the portion of the suture toform the first stitch. The curved needle can pass through the loopformed by the stitch looper to form the first stitch.

In some implementations, a suturing system comprises one or moreautomated fixtures. For example, the system comprises at least a firstautomated fixture. The first automated fixture can comprise a pluralityof motorized actuator devices and a suture target holder. The firstautomated fixture is configured to move or rotate a target suture device(e.g., a heart valve, etc.), for example, when the target suture deviceis mounted to the suture target holder.

In some embodiments, the system also includes at least a secondautomated fixture. In some embodiments, the second automated fixturecomprises a curved needle and can be configured to move the curvedneedle in a fixed path.

In some embodiments, the second automated fixture also includes a stitchlooper. The stitch looper can have one or a plurality of tines. Thestitch looper (e.g., tines of the stitch looper) can be configured tosecure a portion of a suture and to form a loop using the portion of thesuture as the curved needle moves in the fixed path. In someembodiments, the stitch looper moves along a second fixed path thatincludes rotation of the stitch looper to form the loop using theportion of the suture. Movement of the curved needle can be locked orsynchronized to movement of the stitch looper.

In some embodiments, the first automated fixture and the secondautomated fixture of the system are arranged relative to each other andconfigured such that the first automated fixture can move the targetsuture device in three dimensions to position the target suture devicein the path of the curved needle. The system and component or fixturesthereof can be configured to implement a predetermined suturing patternon the target suture device.

In some embodiments, the first automated fixture comprises a firstcontroller configured to direct the first automated fixture how toposition the target suture device. In some embodiments, the secondautomated fixture comprises a second controller configured to direct thesecond automated fixture when to move the curved needle to implement thesuturing pattern.

The second automated fixture can include a tensioning device that cankeep a suture in a state of constant tension when implementing thesuturing pattern.

In some embodiments, the first automated fixture is configured to movethe target suture device in at least four directions. The firstautomated fixture can comprise an articulation arm.

The system, e.g., the second automated fixture of the system, can beconfigured such that the curved needle is used to implement the suturingpattern as a single suture stitching.

Other steps, features, components, etc. not specifically mentioned inthese examples, but described elsewhere herein or otherwise known canalso be included and/or used with the examples described here.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings forillustrative purposes and should in no way be interpreted as limitingthe scope of any of the inventions disclosed herein. In addition,various features of different disclosed embodiments can be combined toform additional embodiments, which are part of this disclosure.Throughout the drawings, reference numbers may be reused to indicatecorrespondence between reference elements.

FIG. 1 illustrates an example of an implantable prosthetic valve device.

FIG. 2 illustrates a perspective view of an example of anotherprosthetic heart valve.

FIG. 3A illustrates a frame for a support stent for an example surgicalvalve.

FIG. 3B illustrates the frame of FIG. 3A covered with fabric.

FIG. 4 illustrates an example of an operator performing operations on animplant device.

FIG. 5 illustrates a close-up view of a heart valve implant device beingsutured using manual holding and suturing.

FIG. 6 illustrates a close-up view of a fabric that can be associatedwith an implant device.

FIG. 7 illustrates a block diagram illustrating an example suturingsystem.

FIG. 8A illustrates a perspective view of an example suturing system.

FIGS. 8B, 8C, 8D, 8E, 8F, 8G, and 8H illustrate an example process forsuturing an implant device using the example suturing system of FIG. 8A.

FIGS. 8I, 8J, 8K, 8L, 8M, 8N, and 8O illustrate another example processfor suturing an implant device using the example suturing system of FIG.8A.

FIG. 9 illustrates a block diagram of an example control system forcontrolling an automated suture fixture.

FIG. 10 illustrates an example distal articulation arm of an automatedsuture fixture coupled to a holder component.

DETAILED DESCRIPTION

Although certain preferred embodiments and examples are disclosed below,inventive subject matter extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and tomodifications and equivalents thereof. Thus, the scope of the claimsthat may arise here from is not limited by any of the particularembodiments described below. For example, in any method or processdisclosed herein, the acts or operations of the method or process may beperformed in any suitable sequence and are not necessarily limited toany particular disclosed sequence. Further, one or more steps disclosedwith respect to one method may be incorporated into other methodsdisclosed herein. Various operations may be described as multiplediscrete operations in turn, in a manner that may be helpful inunderstanding certain embodiments; however, the order of descriptionshould not be construed to imply that these operations are orderdependent. Additionally, the structures, systems, and/or devicesdescribed herein may be embodied as integrated components or as separatecomponents. For purposes of comparing various embodiments, certainaspects and advantages of these embodiments are described. Notnecessarily all such aspects or advantages are achieved by anyparticular embodiment. Thus, for example, various embodiments may becarried out in a manner that achieves or optimizes one advantage orgroup of advantages as taught herein without necessarily achieving otheraspects or advantages as may also be taught or suggested herein.Features described with respect to one exemplary embodiment may beincorporated into other embodiments disclosed herein even if notspecifically described with respect to the embodiment.

Prosthetic heart valve implants, as well as many other types ofprosthetic implant devices and other types of devices, can comprisevarious sutured components and/or portions. For example, a sealingportion, skirt, etc. can be sutured to a frame of a prosthetic heartvalve to help prevent blood from leaking around the outer edges orcircumference of the prosthetic heart valve. Execution of sutures by ahuman operator may be relatively difficult and/or cumbersome in certainconditions. For example, where small stitches are to be made with highprecision, the complexity and/or associated operator burden may resultin injury and/or undesirably low quality of products. Furthermore,certain heart valve implant devices may require hundreds of sutures,which can involve substantially labor-intensive and error-susceptiblesuturing procedures. Therefore, adding automation to suturing ofimplants can be desirable to improve quality, speed of manufacture,and/or help prevent issues associated with human operators.

Certain embodiments disclosed herein provide heart valve suturingsystems, devices, and/or methods for performing suturing proceduresinvolving the physical manipulation and/or positioning of one or moreautomated mechanical articulating fixtures, components and/orsubassemblies. Such articulating fixture(s) or component(s) may beconfigured to hold or secure a prosthetic human heart valve implantdevice, or other suturing subject or implant device having one or morecomponents or portions that may advantageously be sutured together. Thevarious embodiments relating to heart valve suturing presented hereincan be applicable to heart valves having any type of suturing and/orstructural configuration or pattern. Examples of heart valve structuresand heart valve suturing techniques that may be applicable to certainembodiments presented herein are disclosed in WIPO Publication No. WO2015/070249, the entire contents of which are hereby expresslyincorporated by reference.

FIG. 1 illustrates an implantable prosthetic human valve device 110according to one or more embodiments. The features of valve 110described herein can apply to other valves, including other valvesdescribed elsewhere herein. The valve 110 can be, for example, atranscatheter heart valve (THV), balloon-expandable heart valve, and/ormechanically-expandable heart valve. The valve 110 in the illustratedembodiment can generally comprise a frame, or stent, 112, a leafletstructure 193 supported by the frame 112, and a sealing member or skirt116 secured (e.g., sutured) to the outer surface of the leafletstructure 193. In certain embodiments, the valve 110 is configured to beimplanted in the annulus of a native heart valve of a human, such as anaortic valve. However, the valve 110 can additionally or alternativelybe adapted to be implanted in other native valves of the heart, or invarious other vasculature, ducts, or orifices of the body, or in grafts,docking stents, docking stations, rings, etc. implanted in the body. Thelower end 180, according to the illustrated orientation, of the valve110 represents an inflow end, while the upper end 182, according to theillustrated orientation, of the valve 110 represents an outflow end.

The valve 110 and the frame 112 can be configured to be radiallycollapsible to a collapsed or crimped state or configuration forintroduction into the body using a delivery catheter, and further can beconfigured to be radially expandable to an expanded state orconfiguration for implanting the valve at a desired location in the body(e.g., the native aortic valve). In certain embodiments, the frame 112comprises a plastic, polymer, shape memory material, or metal expandablematerial that permits crimping of the valve 110 to a smaller profile fordelivery and expansion of the valve. In certain implementations, anexpansion device, such as the balloon of a balloon catheter or a toolfor mechanical expansion, can be used to expand or help expand thevalve. In certain embodiments, the valve 110 is a self-expanding valve,wherein the frame is made of a self-expanding material such as a shapememory material or metal (e.g., Nitinol). Self-expanding valves can beable to be crimped to a smaller profile and held in the crimped statewith a restraining device, such as a sheath covering the valve. When thevalve is positioned at or near the target site, the restraining devicecan be removed or retracted to allow the valve to self-expand to itsexpanded, functional size or to a deployed configuration.

The sealing portion or skirt 116 can comprise a single piece or multiplepieces or material (e.g., cloth, polymer, etc.) with opposite ends thatare secured to each other to form the annular shape illustrated in FIG.1 or extend around a circumference of the valve. In certain embodiments,the upper edge of the sealing portion or skirt 116 has an undulatingshape that generally follows the shape of struts of the frame 112. Inthis manner, the upper edge portions of the sealing portion or skirt 116can be tightly secured to respective struts with sutures 156. Thesealing portion or skirt 116 can be placed on the outside of the frame112 or on the inside of the frame 112 (as illustrated) and an upper edgeportion of the sealing portion or skirt 116 can be wrapped around theupper surfaces of the frame struts and secured in place with sutures.The sutures 156 provide a durable attachment of the sealing portion orskirt 116 to the frame 112.

The leaflet structure 193 can comprise three leaflets (as illustrated inFIG. 1 ) in certain embodiments, which can be arranged to collapse in atricuspid arrangement. Although a three-leaflet embodiment isillustrated, it should be understood that valve implants suturedaccording to embodiments disclosed herein can have any number ofleaflets, such as, for example, two or four. The leaflets 193 can beformed from separate flaps of material or tissue or all three leafletscan be derived from a single material. The lower edge of leafletstructure 193 can have a variety of shapes. In certain embodiments, thelower edge of the leaflet structure 193 can have an undulating, curved,and/or scalloped shape that can be sutured to the frame 112. Theleaflets 193 can be secured to one another at their adjacent sides toform commissures 184 of the leaflet structure, where the edges of theleaflets come together. The leaflet structure 193 can be secured to theframe 112 using any suitable techniques and/or mechanisms. For example,the commissures 184 of the leaflet structure can be aligned with thesupport posts 118 and secured thereto, e.g., using sutures, adhesive,clamping portions, crimping, and/or other attachment means. In certainimplementations, the point of attachment of the leaflets 193 to theposts 118 can be reinforced, e.g., with bars comprising a more rigidmaterial or stainless steel.

FIG. 2 illustrates a perspective view of a prosthetic human heart valve210 in accordance with one or more embodiments. The heart valve 210 caninclude a peripheral sealing ring structure 291 configured to providesupport for nesting the heart valve 210 in a heart valve cavity and/orresting upon, or attached to, an annulus or other structure of theheart. The valve 210 can further include a frame member 292, such as ametal frame, which can provide support for a plurality of flexibleleaflets 293 and can define three upstanding commissure posts 294,wherein the leaflets 293 can be supported between the commissure posts294. In certain implementations, as illustrated in FIG. 2 , the sealingring 291 can attach around the periphery of the frame member 294 at theinflow end of the valve 210, with the commissure posts 294 projecting inthe outflow direction.

The leaflets 293 can be formed from separate flaps of material or tissueor all three leaflets can be derived from a single material. Theleaflets 293 can be secured and supported both by the commissure posts294, as well as along arcuate cusps of the frame member between thecommissure posts.

FIG. 3A illustrates a frame 392 for a support stent for a surgical heartvalve such as the valve 210 of FIG. 2 . The frame 392 can includemultiple cusps curved toward an axial inflow end alternating withmultiple commissures 322 projecting toward an axial outflow end, thesupport stent 392 defining an undulating outflow edge. The support stent392 can comprise a wireform 320 having three upstanding commissures 322alternating with three cusps 324 which generally circumscribe acircumference. A stiffening band 326 can be disposed within or withoutthe wireform 320. The inflow edge of the band 326 can conform or atleast partially conform to the cusps 324 of the wireform 320 and can becurved in the outflow direction in between in the region of the wireformcommissures 322, e.g., as illustrated in FIG. 3A. In some embodiments,the support stent 392 provides the supporting structure of a one-wayprosthetic heart valve (e.g., valve 210) of FIG. 2 .

FIG. 3B illustrates the frame of FIG. 3A covered with fabric 340,wherein the fabric 340 can be sutured in one or more portions in orderto secure the fabric 340 as a covering for the frame 392. Thefabric-covered support stent 342 can be generally tubular and caninclude multiple cusps 344 curved toward an axial inflow end alternatingwith multiple commissures 346 projecting toward an axial outflow end.The support stent 342 can comprise an undulating outflow edge aboutwhich the fabric 340 is secured held. In certain embodiments, a seam 350is sutured adjacent an inflow edge 352 that secures the fabric 340 aboutthe support stent. The seam 350 is illustrated slightly axially abovethe inflow edge 352 for clarity, although it can be located directly atthe inflow edge or even inside the support stent. In certainimplementations, one or more seams can be located in other positionsalong the fabric. The sutures of the support stent 342 can be executedor added in multiple ways. Furthermore, although certain stitches areillustrated in FIG. 3B, the support stent 342 and/or valve implant 210of FIG. 2 can comprise any type or number of stitches or sutures. Forexample, the support stent 342 and/or one or more other components ofthe associated implant device, can also have leaflets and/or othermaterials sutured thereto.

Suturing of prosthetic heart valve devices and/or other implant devices,such as those described above, can be performed in various ways. Forexample, certain handheld processes for suturing prosthetic humanimplant devices can be implemented in which an operator utilizes bothhands for holding, securing, and/or suturing the implant device. FIG. 4illustrates an operator 405 performing operations on a prosthetic humanimplant device 410. For example, the operator 405 can suture an outerwireframe of the device 410 to an inner skirt or cloth, as describedabove, where the implant device 410 is a transcatheter heart valvedevice. Alternatively, the implant device 410 can be a surgical valvedevice, or other type of implant device. The implant device 410 can bethe same as or similar to one of the valves illustrated herein or can bea different type of valve or implant device.

As illustrated in the diagram of FIG. 4 , in some processes, an operator405 may need to utilize both of the operator's hands for executingrelevant suturing operations. For example, a first hand 406 may be usedto hold and/or secure the implant device 410, and a second hand 407 maybe used to manually operate a suturing needle or the like.

In order for the operator 405 to effectively execute the relevantsuturing operations on the implant device 410, it may be necessary ordesirable for the view of the implant device 410 to be magnified orotherwise enhanced in some manner. For example, as illustrated, theoperator may further utilize a magnification system 460, such as amicroscope, which may comprise an eyepiece component 461 as well as oneor more lenses and/or refractive elements 463. In certain embodiments,the magnification system 460 is designed such that the operator 405 mayhave a line of sight 409 at a first angle, wherein the magnificationsystem 460 is configured to at least partially reflect light therein ata downward angle 408 to focus on a target focal plane below.

FIG. 5 illustrates a close-up view of a prosthetic human implant devicebeing sutured using manual holding and suturing, as described above. Asillustrated, for handheld suturing solutions, a first hand 506 may berequired to hold the target implant device 510, while a second hand 507may be required to manipulate the suturing needle 509, or the like.According to certain processes, the operator may be required to hold oneor more hands in substantially constant focus of a microscope overprolonged periods of time. Furthermore, the operator may be required tosqueeze, push, pull, or otherwise exert manual force on one or moreportions of the target implant device 510 and/or suture needle 509.

FIG. 6 illustrates a close-up view of a fabric associated with animplant device according to one or more embodiments. Such fabrics maycomprise woven strands forming ribs having relatively small gapstherebetween. For example, each rib in a fabric region to be sutured mayhave a thickness t of approximately 0.2 mm, or less. For certainprocesses, one may necessarily or desirably wish to position and sewsuch a fabric within one-rib accuracy. Thus, precise positioning andfocusing of suturing components and targets is desirable.

To address issues identified above and to meet demand for heart valvesand other implants, automation of the sewing operation could bebeneficial in manufacturing, e.g., to cut down on touch time, humanerror, cost, etc.

Certain embodiments disclosed herein provide systems and processes forsuturing components and/or devices (e.g., prosthetic implant devices)using multi-access systems and/or sewing systems for suturing implantdevices. Such systems may be configured to articulate a component ordevice (e.g., an implant device such as a human prosthetic heart valvedevice, etc.) wherein the precise positioning of the component or devicemay allow for necessary or desirable suturing operations. Furthermore,the system may be further configured to reposition the component ordevice for a subsequent operation (e.g., a subsequent suture operation).

Suturing an implant device or heart valve can require suture accuracywithin a millimeter, half a millimeter, or less, but a suture locationmay be easily missed between ribs or threads, especially whenimplementing dual-handheld suturing procedures. Embodiments of thepresent disclosure may facilitate improved precision and may help reduceor eliminate human error.

Positional accuracy may be improved with respect to embodiments of thepresent disclosure through the use of systems incorporating one or morecameras, sensors, articulation arms, automated fixtures, etc., and/or acombination of more than one of these for correctly positioning andidentifying desired positions (e.g., suture positions, etc.), such aswith respect to frame and skirt suturing for a transcatheter heart valveor other target device. Quality-controlled feedback for furtherimproving quality for manufacturing can also be implemented, e.g., usingsensors, imaging, and/or feedback mechanisms.

Embodiments disclosed herein provide for systems, devices, methods, etc.for executing one or more operations (e.g., suturing operations, reviewor inspection operations, and/or other operations) for prostheticimplant devices (e.g., prosthetic heart valves) for humans and/or othertypes of devices or components. The systems herein can be fully ormostly automated systems. The fully or mostly automated systems caninclude one or multiple automated fixtures. For example, a firstautomated fixture (which can be the same as or similar to the automatedfixtures or automated suture fixtures described and illustrated herein)can be used to articulate and move an implant device to various desiredpositions for processing operations or steps (e.g., suturing, treatment,applications, etc.), while a second automated fixture or device could beused to perform the processing operations or steps at the variousdesired positions. For example, the second automated fixture can actsimilar to a sewing machine that moves a needle in and out (e.g., whichcan be done in a single plane and/or along a linear or curved path) toadd the sutures to a target or implant device while the first automatedfixture moves the target or implant device to the correct position toreceive the desired suture in the correct location on the target orimplant device. The automated sewing systems described herein can beprogrammed with a previously specified sewing pattern of an implant orheart valve. Suture tensioning management could also be used to maintainand use proper tensioning.

In certain implementations, a fully (or mostly) automated sewing processfor one or multiple sewing operations can include two sub-systems orautomated fixtures, in which one sub-system or automated fixture isconfigured to sew the pattern by translating movement of a needle whilethe other sub-system or automated fixture is coordinated or synchronizedtherewith and can utilize a multi-axis articulating arm (e.g., afive-axis robotic arm) to grip and move the target implant as desiredfor sewing. Within the sewing sub-system or automated fixture, varioustypes of needles can be used. Also, the sewing sub-system or automatedfixture can include a suture tensioning device configured to maintainthe suture or thread attached to the needle in constant tension to avoidproblems associated with slack in the suture or thread line (e.g., riskof entanglement, etc.). The implant holding sub-system or automatedfixture can include a gripper that does not damage the implant and canbe configured to accurately map the path of the implant holding deviceand an implant held thereby.

FIG. 7 illustrates a block diagram of an exemplary suturing system 700,and FIG. 8A illustrates a perspective view of an exemplary version ofthe system 700. One or more components of the system 700 can be utilizedfor suturing heart valve devices or other implant devices, as describedherein. The depiction of the system 700 in FIGS. 7 and 8A is meant to beillustrative and not limiting, so various components illustrated inFIGS. 7 and 8A can be omitted from the system 700 and other componentsnot illustrated in FIGS. 7 and 8A can be added to the system 700. Theseare not drawn to scale and components can be various sizes. For example,in certain implementations, the needle is configured to be smaller thanillustrated in FIG. 8A to make the suture line and punctures smaller andmore precise.

As illustrated in FIG. 7 , the system 700 can include one or more powerinputs, a first automated fixture 710 (e.g., such as a sewing machine),a second automated fixture 720 (e.g., such as a multi axis robot or fiveaxis robot), a feedback microcontroller unit (MCU), etc. In someembodiments, the power input is outlet power (e.g., of 110 volts) thatcan be configured to power one or both of the automated fixtures (e.g.,one or both of an articulating arm and a sewing machine fixture), butother power inputs are also possible.

The first automated fixture 710 can include a controller (e.g., microcontroller), one or more actuators, a thread or suture feed system,programming, a needle holder or needle gripper, circuitry, a constanttension component, arduino, a gripper motor, one or more sensors,wiring, and/or other components. The second automated fixture 720 caninclude a controller (e.g., micro controller), one or more actuators, agripping fixture, programming, circuitry, one or more sensors, CM-700,wiring, and/or other components. The first automated fixture 710 and thesecond automated fixture 720 can be integrated and synchronized toperform sewing functions with the first automated fixture 710 (e.g.,sewing machine) performing the suturing operations on a targetimplantable device held and moved into desired positions by the secondautomated fixture 720 (e.g., a multi-axis robotic arm).

In some embodiments, the system 700, for example one or more of theautomated fixtures, includes one or more controllers (e.g., microcontrollers) configured to direct one or more components of theautomated fixtures and/or other components according to a suturingprocess. The controller(s) can comprise one or more hardware and/orsoftware components designed to generate and/or provide fixture controlsignals (e.g., suture fixture control signals) and/or data associatedwith one or more steps of a suturing process. For example, thecontroller(s) can comprise a computing device including one or moreprocessors, as well as one or more data storage devices or components,which can include volatile and/or nonvolatile data storage media. Incertain embodiments, the data storage is configured to store processscript data (e.g., suture process script data), which can comprise dataindicating positioning of one or more components and/or fixtures of thesystem 700 for various steps and/or stages of the suturing process. Aprocess comprising a plurality of steps can be represented at least inpart by numeric or other data sets representing positioning informationfor one or more components of the automated fixtures and/or one or moreadditional components of the system 700 for each respective step orstage of the process. For example, a suturing process comprising aplurality of suturing steps can be represented at least in part bynumeric or other data sets representing positioning information for oneor more components and/or fixtures of the system of the system 700 foreach respective step or stage of the suturing process.

The automated fixture 710 can comprise a needle 740. Various needles canbe used. A non-corrosive curved needle comprising one or more ofNiTi/Nitinol, Delrin, cobalt chromium, ABS plastic, PEEK plastic, strongplastic having a polycarbonate base can be used. The needle 740 can becurved into a semi-circular shape or a curved shape that does not form acomplete circle. For example, in certain implementations, the needle hasa curved shape forming an arc between 70 degrees and 220 degrees ofrotation of a circle or between 100 degrees and 190 degrees.

The automated fixture 710 can comprise a needle gripper or needlegripping mechanism configured to hold the needle during sewing process.The needle gripper can comprise a drill chuck tool-holder, can usevacuum pressure, can comprise a mechanical gripper, etc. The automatedfixture 710 can also comprise a tensioning device 730, such as a systemused to hold the spool of thread that is easily adjustable and that cankeep the thread in constant tension. The tensioning device 730 cancomprise a spring system; a bolt and spring system; a bolt, nut, andspring system; a bobby tension meter; a PID controller; etc.

The automated fixture 720 can include a holder or holder assembly (e.g.,a gripper or gripping fixture) configured to hold the target implantwhile sewing occurs. For example, a gripper can be a multi-prong gripper(e.g., a two or a three-prong gripper) configured to hold the implantwhile sewing occurs. Optionally, the gripper can be an inside-bellowgripper, a pronged gripper, a 3-D printed gripper, a caged gripper, oranother type of gripper. In some embodiments, a suture target holderassembly configured to hold or secure the suture target (e.g., theprosthetic implant device) can be similar to the target holder assemblyillustrated in FIG. 10 .

The automated fixture 720 can also include various sensors. For example,the fixture can include sensors to detect the position and rotation ofthe valve fixture during the sewing process and forces involved in theprocess. For example, the automated fixture 720 can also include agripping force sensor, which can be configured to relay the force thatthe gripper exerts on the implant. The automated fixture 720 can alsoinclude a gyroscope sensor, which can be configured to measure therotation of the second automated fixture or an articulation arm thereof.The automated fixture 720 can also include an accelerometer sensor,which can be configured to measure the position of the end effector ofthe automated fixture or an articulation arm thereof.

While sewing operations with multiple sutures or threads are possible,in certain implementations, the automated fixture 720 is configured toperform a single suture or thread sewing operation to reduce the amountof suture or thread used and the volume of the implant. The automatedfixture 710 can be configured as a modified hemming-like machine with acurved needle, thereby the process of transferring the needle after eachpass through the material could be eliminated to allow a single threadoperation. One way to do this is to use a machine that can sew or applya suture or thread similar to a hemming machine or a blind stitchhemming machine, where the machine has been specially adapted and sizedfor use with an implant and coordinated with an automated fixture thatautomatically moves the implant as desired during suturing. Examples ofprocedures using such machines are illustrated in FIGS. 8B-8O. Thecurved needle can include an eyelet near the sharp or penetrating end ofthe needle (or between the end and another point along the needle, e.g.,the middle of the needle) through which the suture or thread passes andthe curved needle can direct the suture or thread into and then out ofthe material (e.g., a cover, seal, leaflet, or other material) beingsewn to a stent or frame as the curved needle rotates. The automatedfixture 720 can also include components that form and pull loops in thesuture or thread to combine with other portions of the suture to formthe stitching along the device. The automated fixture 710 is configuredto move, rotate, etc. the target implant as the automated fixture 720sews (e.g., moving the curved needle along a fixed path) to create adesired suture pattern. The movement of the target implant occurs inthree dimensions. The automated fixtures can be programmed, coordinated,synchronized to work together to accomplish a variety of desired suturepatterns on a variety of implants.

FIGS. 8B-8H illustrate an example process for forming a stitch in atarget device or suture target having a fabric or other material 716(e.g., the skirt 116 described with respect to FIG. 1 ) to be secured toa support structure 712 (e.g., the frame 112 described with respect toFIG. 1 ). The figures illustrate the process using a side cross-sectionview of the material or fabric 716 and the support structure 712 forsimplicity and clarity. As illustrated in FIG. 8B, the process uses aneedle 740 and a stitch looper 745 in an automated fixture (e.g., theautomated fixture 710, an automated sewing fixture, etc.) wherein themovement of the needle 740 and the movement of the stitch looper arecoordinated and/or locked together through the use of a common motor,common gears, or the like. The needle 740 can be a curved needle or astraight needle. The needle 740 holds a suture 743 which is passedthrough an eye of the needle 740. The stitch looper 745 includes two ormore tines configured to hold a portion of the suture 743 and to form aloop with that portion of the suture 743 during the stitching process.The needle 740 can be configured to pass between the tines of the stitchlooper 745 to form a stitch on the material or fabric 716.

FIG. 8C illustrates the needle 740 being inserted through the skirt 116so that the suture passes through the skirt at the insertion point. FIG.8D illustrates the stitch looper 745 moving towards the needle 740 sothat the stitch looper passes between a portion of the suture 743 andthe needle 740. FIG. 8E illustrates the needle 740 being withdrawnthrough the same insertion point. The suture 743 remains wrapped aroundthe stitch looper 745 to maintain a portion of the suture 743 on theopposite side of the material or fabric 716 as the withdrawn needle 740.FIG. 8F illustrates the stitch looper spinning to form a loop in thesuture 743. In addition, the material or fabric 716 is moved relative tothe needle 740 (e.g., by movement of an automated fixture or othermeans). FIG. 8G illustrates the needle 740 being inserted through thematerial or fabric 716 at a new insertion point due to the movement ofthe material or fabric 716 relative to the needle 740. The needle passesthrough the tines of the stitch looper 745 and the loop formed by thesuture 743. As the stitch looper 745 is withdrawn (e.g., moved upward inthe figure), the portion of the suture 743 held by the stitch looper 745slides off of the tines of the stitch looper 745 so that the loop formedby the suture 743 tightens around the portion of the suture 743 held bythe needle 740. FIG. 8H illustrates the stitch 756 formed by thisprocess. The process repeats at the step illustrated in FIG. 8C for astitch in a new location on the material 716.

FIGS. 8I-8O illustrate another example process for forming a stitch in atarget device or suture target with a material or fabric 716 to besecured to a support structure 712. The process uses a curved needle 740and a stitch looper 745 in an automated fixture (e.g., the automatedfixture 710, an automated sewing fixture, etc.). The process isillustrated looking downward onto the material or fabric so that thecurvature of the needle is not evident in the illustrations. However,the curvature of the needle 740 allows the needle 740 to be insertedthrough two points of the material or fabric 716 on either side of thesupport structure without needing to change the angle of the material orfabric 716 and/or without needing to pinch or bunch the material orfabric 716.

FIG. 8I illustrates the curved needle 740 securing the suture 743through an eye of the needle 740 at a distal end of the needle 740. Thestitch looper 745 includes multiple tines configured to secure a portionof the suture 743 during the process. The stitch looper 745 isconfigured to hold a portion of the suture 743 while the needle 740 iswithdrawn through the insertion points. The stitch looper 745 is alsoconfigured to form a loop in the suture 743 and to position the loopformed by the suture so that the needle 740 passes through the formedloop prior to creating new insertion points for the next stitch.

FIG. 8J illustrates the needle 740 forming two insertion points thatpass through the material or fabric 716 under the support structure 712.The two insertion points are configured to be at complementary targetedlocations to form a stitch that secures the material or fabric 716 tothe support structure 712. FIG. 8K illustrates the stitch looper 745moving toward the needle 740 to secure a portion of the suture. Thestitch looper 745 passes between a portion of the suture 743 and theneedle 740 to secure the portion of the suture 745. FIG. 8L illustratesthe needle 740 being withdrawn through the same insertion points theneedle 740 just created while the stitch looper 745 secures a portion ofthe suture 743 so that the portion of the suture 743 does not passthrough those insertion points. FIG. 8M illustrates the stitch looper745 moving toward the withdrawn needle in a way that also rotates thestitch looper 745. This movement produces a loop in the suture 743. FIG.8N illustrates the fabric 716 being moved so that as the needle 740 isagain being advanced, it will create two new insertion points. As theneedle 740 advances, it passes through the loop formed by the suture 743on the stitch looper 745. FIG. 8O illustrates the stitch looper 745after it has been withdrawn and returned to its starting location. Thismovement of the stitch looper 745 causes the loop formed by the suture743 to be removed from the stitch looper 745. In addition, advancementof the needle 740 through the two new insertion points pulls the loopformed by the suture 743 to tighten the loop around the suture 743,thereby forming the stitch 756. This process then repeats at the stepillustrated in FIG. 8J to form additional stitches.

Advantageously, the processes described and illustrated in FIGS. 8B-8Ocan be used to form stitches in a fabric wherein the needle used to formthe stitches is never released during the process.

With reference to FIGS. 7 and 8A, the system 700 can include a frame onwhich one or more automated fixtures (e.g., both automated fixture 710and automated fixture 720, etc.) could each be mounted. In someembodiments, a frame that measure 16″×12″×12″ can be used. The sides ofthe frame can be closed, or the sides of the frame can be open so thatan operator can see the process happening and examine the fixture forany errors. The automated fixture 720 can be mounted to the front of themachine so that it could exit the sewing area, pick up the targetimplant and rotate back into the sewing area.

In certain embodiments, the automated suture fixture or fixturescomprise one or a plurality of motorized actuators (e.g., servoactuators) physically coupled to one another. By constructing theautomated suture fixtures using one or a plurality of motor components(e.g., servo motor components), the system 700 may be relativelyinexpensive and/or advantageously provide an enhanced range of motion,as well as multiple axes of rotation. In certain embodiments, one ormore of the automated suture fixtures comprises a plurality of actuatordevices (e.g., servo actuator devices) daisy-chained together andimplemented using a software script to provide cooperative functionalityfor the purpose positioning the target implant device. For example, theactuator devices or servo actuator devices (e.g., servo motor devices)can be mounted, or configured to be mounted, horizontally or verticallyor at an angle, and can be articulated in any direction.

In some embodiments, the second automated suture fixture or assemblycomprises one or more components configured to articulate, operate,and/or position one or more motorized actuators to present a targetdevice (e.g., a heart valve, implant, or other suture target), in adesirable or suitable position or presentation for convenient engagementor interaction therewith by another fixture executing at least part of aprocess (e.g., a suturing process). In certain embodiments, theautomated suture fixture includes a plurality of motorized actuatorsthat are mounted, attached, or connected to one another in a desirableconfiguration to provide a desirable range of motion for the automatedfixture (e.g., automated suture fixture) for the purpose of articulatinga target (e.g., a suture target) associated with or held by theautomated fixture. In certain embodiments, a target holder component orassembly can be associated with, or connected to, one or more of themotorized actuators. The motorized actuators can each comprise one ormore rotating or otherwise articulating members driven by a motor or thelike. Examples of automated suture fixtures and associated componentsare illustrated in greater detail in FIGS. 7 and 8A and are describedherein in greater detail in connection therewith.

In certain embodiments, the controller(s) provides one or more controlsignals for directing the positioning and/or operation of the fixtures(or motorized actuators of the fixtures) based on a positioning script,suture process script, and/or user input provided by an operator. Forexample, the system 700 (or a system 1000 described herein withreference to FIG. 9 ) can include a user input device (e.g., such asuser input device 1010 illustrated in FIG. 9 ), which can be used by anoperator to provide input initiating or directing the operation of thecontroller and/or automated suture fixture assembly. For example, userinput device 1010 can comprise any suitable user input interface, suchas a mechanism for user input in connection with a graphic userinterface associated with an electronic display, wherein an operator canprovide input through interaction with the interface. In someembodiments, the user input device comprises one or more physicalswitches, buttons, pedals, sensors, or the like, wherein a user mayprovide input through engagement of such mechanism (s). In someembodiments, the input can be provided using voice commands and/or voicerecognition software. A signal or signals can be transmitted to advancefrom one step or stage of the present suturing operation to a subsequentstep or stage, e.g., an input can be provided to the controller toadvance the system through a script moving the automated fixture andtarget to each position in sequence. These can be coordinated such thatthe target is always moved to a position where the known, consistentpath or fixed path of the needle will not contact a frame or metal ofthe implant to avoid damage to the needle and other problems.

The configuration of the automated suture fixture(s) can provide for aweight and/or size for the automated suture fixture(s) that isrelatively small and convenient for use in applications designed toassist in the positioning and manipulation of relatively small devices,such as the prosthetic human implant device. The relatively small sizeof the system and automated fixture also allows for use in a morecompact workspace like those often used for suturing prosthetic heartvalve implants, e.g., the small size can fit and be used even on arelatively small desk or table, which allows for more efficient use ofbuilding and work areas. In certain embodiments, the individual actuatordevices (e.g., the individual servo actuator devices) of the automatedsuture fixture(s) comprise brushless potentiostat and/or magneticencoder devices. In certain embodiments the actuator devices areimplemented using piezoelectric control with analog voltage signals. Incertain embodiments, one or more components of the automated suturefixture(s) are controlled using pulse width modulation control signals,such as control signals spaced by between 0 to 2 μs, for example. Incertain embodiments, multiple motor components (e.g., multiple servomotor components) of the automated suture fixture(s) share one or morecommon leads with a multiplex signal, such as a three-lead connection.In certain embodiments, the automated suture fixture(s) comprise four orfive or more servo motor devices. Devices and fixtures disclosed hereincan be remote-controllable or partially remote-controllable.

Suture systems in accordance with the present disclosure can compriseone or more automated suture fixtures, e.g., an automated suture fixture720 for articulating a suture target (e.g., prosthetic human heart valveimplant) to a desired suture position or other process position. FIG. 9illustrates a block diagram illustrating an exemplary control system1000 for controlling an automated suture fixture 1070. The automatedsuture fixture 1070 (which can represent any or all of the automatedfixtures described above) is configured to receive control signals froma controller module 1030. The controller module 1030 can comprise acombination of software and/or hardware components configured togenerate control signals for at least partially directing the operationof the automated suture fixture 1070 and/or one or more componentsthereof.

In certain embodiments, the controller 1030 includes one or moreprocessors and/or controller circuitry configured to access suturingscript information 1034 or other script or program informationmaintained by the controller in data storage thereof, or otherwiseaccessed by the controller 1030. The controller 1034 can includepositioning control circuitry 1032 designed to interpret suturing scriptinformation or other script or program information and generate controlsignals for controlling the automated suture fixture 1070 and/or anotherautomated fixture based at least in part thereon.

The suturing script information 1034 or other script or programinformation can comprise sequential positioning information for one ormore components of the automated suture fixture(s) 1070 with respect toone or more suturing processes or other processes that the controller1030 is designed to implement. For example, in some embodiments, thepositioning control circuitry 1032 is configured to provide positioninformation for each step of a suturing process in sequence. Theadvancement from one position step to another can be directed by thecontroller 1030 based on a timer, or user input or other mechanism.

The automated suture fixture 1070 can include a plurality of motorizedactuators 1071, which can be communicatively coupled to the controller1030. In certain embodiments, the motorized actuators are coupled to oneanother in a daisy-chain configuration, wherein two or more of themotorized actuators are coupled or wired together in sequence.

Each of the motorized actuators 1071 can include a motor, such as a DC,AC, or brushless DC motor. The motor can be a servo motor. In certainembodiments, the motor 1072 is controlled using pulse-coded modulation(PCM), as directed by the motor control circuitry 1076. For example, themotor control circuitry 1076 can apply a pulse application for a certainperiod of time, wherein the angular positioning of a rotor component1073 is determined at least in part by the length of the pulses. Theamount of power applied to the motor 1072 can be proportional to therotational distance of the rotor 1073.

In certain embodiments, the motorized actuators are servo actuatordevices including one or more servo feedback component(s) 1074, such asa position sensor (e.g., a digital encoder, magnetic encoder, laser(s),etc.). Use of servo feedback component(s) 1074 may be desirable in orderto achieve a desirable level of confidence that the motorized actuators1071 are positioned as directed by the controller 1030 with anacceptable degree of accuracy. The servo feedback component(s) 1074 canprovide an analog signal to the motor control circuitry 1076 indicatinga position and/or speed of the rotor 1073, which may advantageouslyallow for relatively precise control of position for faster achievementof a stable and accurate rotor position. Relatively accurate positioningof an implant device may be necessary or desirable due at least in partto the dimensions of the material or cloth of a heart valve or otherimplant device that is sutured in an implant suturing operation usingthe automated suture fixture 1070. For example, the fabric or othermaterial being sutured can comprise woven strands forming ribs havingrelatively small gaps therebetween. In certain embodiments, theautomated suture fixture 1070 can be configured to articulate a suturetarget prosthetic human implant device within 0.2 mm accuracy, or less.Although servo motor devices and components are described, in someembodiments, one or more motorized actuators can comprise steppermotors, or other types of motor subsystems.

The motorized actuators 1071 can further comprise motor controlcircuitry 1076, which can drive the motor 1072 according to the controlsignals received from the controller 1030. In certain embodiments, themotor 1072, in combination with the servo feedback mechanism 1074 and/ormotor control circuitry 1076, can advantageously be configured to retainthe rotor 1073 and/or attached support member in a set position fordesired periods of time. The motor 1072 can provide relatively smoothcommutation and/or accurate positioning of the associated rotor 1073.The motor 1072 can be relatively powerful relative to its size and maydraw power proportional to the mechanical load present on the rotor 1073and/or associated support member.

In some embodiments, the servo feedback component 1074 comprises apotentiometer that is connected to the rotor 1073, which can be theoutput device of the motorized actuator 1071. The rotor 1073 can link tothe potentiometer and control circuitry 1076, wherein the potentiometer,coupled with signals from the control circuitry, controls the angle ofthe rotor 1073 (and associated support member) across a rotationalrange, such as between 0°-180°, or further. In certain embodiments, therotational range of the rotor 1073 is restricted by one or moremechanical stops, which can be built into associated gear mechanism(s).The potentiometer (or other servo mechanism, such as an internal rotaryencoder) can allow the control circuitry 1076 to monitor the currentangle of the motor or rotor. When the rotor 1073 is at the correctangle, the motor 1072 can idle until the next positioning signal isreceived from the controller 1030.

The automated suture fixture 1070 can further include a suture targetholder device or assembly 1080 (while called a suture target holder orassembly herein, this can be another type of target holder device,gripper, or assembly to hold target devices or components for otherprocedures). The suture target holder 1080 can be physically coupled toone of the motorized actuators 1071, such as to distal extension armactuator device of the plurality of actuators. The suture target holder1080 can be configured to hold or have mounted thereto a prostheticheart valve device, or other prosthetic human implant device, which isdesired to be sutured. The suture target holder 1080 can have anysuitable or desirable shape, configuration and/or dimensions and can beconfigured to hold or secure a target device or implant device in avariety of different ways. An example embodiment of suture target holderdevice or assembly is described below in connection with FIG. 10 .However, it should be understood that such an embodiment is providedmerely as an example, and other types of suture target holders can beimplemented in the disclosed systems.

FIG. 10 illustrates an articulation arm 1878 and/or one or moreactuators coupled to an exemplary holder component 1880. In certainembodiments, a holder component 1880 is fixed or secured to the distalarticulation arm 1878 or end actuator of an automated suture fixture forthe purpose of providing an interface for securing an implant device orother target form or device. The holder component or assembly 1880 canbe designed or configured to hold or secure an implant device or othertarget device, or portion thereof, for the purpose of allowing suturingthereof according to any process or embodiment disclosed herein. Theholder component 1880 can be configured to secure or otherwise include acylinder form 1885, which can be sized or dimensioned to have pulledthereover the target device or implant (e.g., a fabric-covered supportstent for a surgical valve implant device 1818). For example, the valveimplant device 1818 can comprise a plurality of commissure post portions1892, as illustrated, which can be positioned such that they areoriented in a direction towards the holder component 1880, such that aseam 1818 can be stitched above what will ultimately represent an inflowedge of the implant device 1818. The cylindrical form or component 1885can be designed in a similar manner to a handheld implant device holder,which can be used in certain embodiments in executing suturingprocedures without the assistance of the articulation arm 1878 andassociated components. The cloth 1825 can be disposed about a rigidwireframe structure, wherein the seam of stitches 1818 is executed inorder to substantially cover the wireframe with the cloth 1825. The seam1818 can secure the cloth 1825 about a stiffening band, as illustratedin FIG. 3A and described.

The holder component 1880 can be designed for a particular application,such as for a transcatheter heart valve suturing application, or asurgical heart valve suturing operation, or other implant suturingprocedure. The valves can be for animal (e.g., for human) use. Althougha surgical valve configuration is illustrated in FIG. 10 , it should beunderstood that the holder device 1880 and/or other components of FIG.10 can be designed or configured to support suturing processes and/orother processes for a transcatheter heart valve or other valve or otherdevice. For example, although the diagram of FIG. 10 illustrates acylindrical form 1885 designed to hold the implant device 1818 in adesired position, such cylindrical form may not be necessary withrespect to a transcatheter heart valve. For example, in place of thecylindrical form 1885, the holder 1880 can instead be configured tosecure a rigid cylindrical wireframe of a transcatheter heart valve, anembodiment of which is illustrated and described above in connectionwith FIG. 1 .

The specific type of holder that is utilized for a procedure orapplication (e.g., for a suture assist application) can be determined ona process-by-process basis. That is, specific adapters may be suitableor desirable for each of separate operations or procedures, or forseparate types of valves or other targets. In certain embodiments, asingle suturing procedure of an implant device can involve use ofmultiple different types of holder devices.

A suturing procedure can be performed after a suture system has beenprogrammed with a certain procedure, program, or script. One or morecomputer components, such as one or more processors and/or memorydevices, can be utilized to store and execute a procedure-directingscript or program, such that a procedure script or program may be playedback for an operator on-demand.

The procedure can include loading a suturing process script or program,which can be pre-programmed. The desired script or program can be loadedin various ways, e.g., by providing input to the system or a computer ofthe system to load the desired script or program from storage or memory

The procedure can involve triggering the positioning of an automatedsuture fixture (or automated fixture) and/or executing a suturingoperation or other operation or step.

Once the suturing operation or other operation or step has beenexecuted, if the relevant suturing operation or other operation or steprepresents a final operation or step of the suturing procedure or otherprocedure, the process can end. However, if additional steps of thesuturing operation or procedure or other operation or procedure remain,the process can repeat the triggering, positioning, or executing stepswhere a subsequent step of the suturing process or procedure can betriggered, such that the process 1700 can involve completion ofsubsequent step(s).

Depending on the embodiment, certain acts, events, or functions of anyof the processes or algorithms described herein can be performed in adifferent sequence, may be added, merged, or left out altogether. Thus,in certain embodiments, not all described acts or events are necessaryfor the practice of the processes. Moreover, in certain embodiments,acts or events can be performed concurrently rather than sequentially.For example, multi-threaded processing, interrupt processing, and/ormultiple processors or processor cores could be used.

Conditional language used herein, such as, among others, “can,” “could,”“might,” “may,” “e.g.,” and the like, unless specifically statedotherwise, or otherwise understood within the context as used, isintended in its ordinary sense and is generally intended to convey thatcertain embodiments do include, while other embodiments do not include,certain features, elements and/or steps. Thus, such conditional languageis not generally intended to imply that features, elements and/or stepsare in any way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or withoutauthor input or prompting, whether these features, elements and/or stepsare included or are to be performed in any particular embodiment. Theterms “comprising,” “including,” “having,” and the like are synonymous,are used in their ordinary sense, and are used inclusively, in anopen-ended fashion, and do not exclude additional elements, features,acts, operations, and so forth. Also, the term “or” is used in itsinclusive sense (and not in its exclusive sense) so that when used, forexample, to connect a list of elements, the term “or” means one, some,or all of the elements in the list. Conjunctive language such as thephrase “at least one of X, Y and Z,” unless specifically statedotherwise, is understood with the context as used in general to conveythat an item, term, element, etc. may be either X, Y or Z. Thus, suchconjunctive language is not generally intended to imply that certainembodiments require at least one of X, at least one of Y and at leastone of Z to each be present.

It should be appreciated that in the above description of embodiments,various features are sometimes grouped together in a single embodiment,figure, or description thereof for the purpose of streamlining thedisclosure and aiding in the understanding of one or more of the variousinventive aspects. This method of disclosure, however, is not to beinterpreted as reflecting an intention that any claim require morefeatures than are expressly recited in that claim. Moreover, anycomponents, features, or steps illustrated and/or described in aparticular embodiment herein can be applied to or used with any otherembodiment(s). Further, no component, feature, step, or group ofcomponents, features, or steps are necessary or indispensable for eachembodiment. Thus, it is intended that the scope of the inventions hereindisclosed and claimed below should not be limited by the particularembodiments described above, but should be determined only by a fairreading of the claims that follow.

The methods described herein include steps that are indicative of one ormore embodiments of the presented method. Other steps and methods may beconceived that are equivalent in function, logic, or effect to one ormore steps, or portions thereof, of the procedures or methods herein.Additionally, the order in which steps of a particular method occurs mayor may not strictly adhere to the order of the corresponding stepsdescribed. Components, features, steps, etc. described with respect toone embodiment herein can be combined or included in other embodimentsdescribed elsewhere herein.

Components, aspects, features, etc. of the systems, assemblies, devices,apparatuses, methods, etc. described herein can be implemented inhardware, software, or a combination of both. Where components, aspects,features, etc. of the systems, assemblies, devices, apparatuses,methods, etc. described herein are implemented in software, the softwarecan be stored in an executable format on one or more non-transitorymachine-readable mediums. Further, the software and related steps of themethods described above can be implemented in software as a set of dataand instructions. A machine-readable medium includes any mechanism thatprovides (e.g., stores and/or transports) information in a form readableby a machine (e.g., a computer). For example, a machine-readable mediumincludes read only memory (ROM); random access memory (RAM); magneticdisk storage media; optical storage media; flash memory devices; DVD's,electrical, optical, acoustical or other forms of propagated signals(e.g., carrier waves, infrared signals, digital signals, EPROMs,EEPROMs, FLASH, magnetic or optical cards, or any type of media suitablefor storing electronic instructions. Information representing the units,systems, and/or methods stored on the machine-readable medium can beused in the process of creating the units, systems, and/or methodsdescribed herein. Hardware used to implement the invention can includeintegrated circuits, microprocessors, FPGAs, digital signal controllers,stream processors, and/or other components.

What is claimed is:
 1. A method of suturing an implant device, the method comprising: directing a first automated fixture to position an implant device in a first position; directing a second automated fixture to perform a first portion of a suturing procedure by performing the following: passing a needle through a material being sutured to the implant device at a first insertion point, the needle including an eye that secures a suture that sutures the material to the implant device; advancing a stitch looper between a portion of the suture and the needle; withdrawing the needle through the first insertion point with the portion of the suture wrapped around the stitch looper to maintain the portion of the suture on an opposite side of the material as the needle after it is withdrawn; and rotating the stitch looper with the portion of the suture wrapped around the stitch looper to form a loop in the suture; directing the first automated fixture to position the implant device in a second position; and directing the second automated fixture to perform a second portion of the suturing procedure by performing the following: passing the needle through the material at a second insertion point such that the needle passes through the loop formed in the portion of the suture held by the stitch looper; and withdrawing the stitch looper such that the portion of the suture held by the stitch looper slides off the stitch looper and the loop formed in the portion of the suture previously held by the stitch looper tightens around a portion of the suture held by the needle, thereby forming a stitch in the material at or near the first insertion point.
 2. The method of claim 1, wherein the implant device is a prosthetic heart valve.
 3. The method of claim 1, wherein to position the implant device in the second position, the first automated fixture circumferentially rotates the implant device in place.
 4. The method of claim 1, wherein to position the implant device in the second position, the first automated fixture circumferentially moves the implant device in an axial direction.
 5. The method of claim 1 further comprising loading a pre-programmed suturing procedure script using one or more processors configured to at least partially control the first automated fixture and the second automated fixture.
 6. The method of claim 1, wherein the needle comprises a curved needle.
 7. The method of claim 1, wherein the needle passes through the material and is withdrawn through the material along a fixed path.
 8. The method of claim 1, wherein the stitch looper includes two or more tines.
 9. The method of claim 1, wherein a single gearing system of the second automated fixture is configured to control movement of both the needle and the stitch looper.
 10. The method of claim 1, wherein the stitch looper rotates at least half a rotation to form the loop.
 11. A suturing system comprising: a first automated fixture comprising a plurality of motorized actuator devices and a suture target holder, the first automated fixture being configured to rotate the target suture device when mounted to the suture target holder; and a second automated fixture comprising a plurality of motorized actuator devices, a needle, and a stitch looper, the plurality of motorized actuators configured to move the needle in a fixed path and to move the stitch looper in a fixed path and to rotate the stitch looper, the plurality of motorized actuators configured to coordinate movement of the needle and the stitch looper to form a plurality of stitches on the target suture device, wherein the first automated fixture and the second automated fixture execute a suturing procedure that includes: moving the target suture device to a first position; passing the needle through a material being sutured to the target suture device at a first insertion point, the needle including an eye that secures a suture that sutures the material to the implant device; advancing the stitch looper between a portion of the suture and the needle; withdrawing the needle through the first insertion point with the portion of the suture wrapped around the stitch looper to maintain the portion of the suture on an opposite side of the material as the needle after it is withdrawn; rotating the stitch looper with the portion of the suture wrapped around the stitch looper to form a loop in the suture; moving the target suture device to a second position; passing the needle through the material at a second insertion point such that the needle passes through the loop formed in the portion of the suture held by the stitch looper; and withdrawing the stitch looper such that the portion of the suture held by the stitch looper slides off the stitch looper and the loop formed in the portion of the suture previously held by the stitch looper tightens around a portion of the suture held by the needle, thereby forming a stitch in the material at or near the first insertion point.
 12. The suturing system of claim 11, wherein the target suture device is a heart valve.
 13. The suturing system of claim 11, wherein the first automated fixture and the second automated fixture are arranged relative to each other and configured such that the first automated fixture can move the target suture device in three dimensions to position the target suture device so that the fixed path of the needle intersects the target suture device at a targeted location.
 14. The suturing system of claim 11, wherein the second automated fixture further includes a tensioning device that can keep the suture in a state of constant tension when implementing the suturing procedure.
 15. The suturing system of claim 11, wherein the first automated fixture is configured to move the target suture device in at least four directions.
 16. The suturing system of claim 11, wherein the first automated fixture comprises an articulation arm.
 17. The suturing system of claim 11, wherein movement of the needle is locked to movement of the stitch looper.
 18. The suturing system of claim 11, wherein the stitch looper moves along a second fixed path that includes rotation of the stitch looper to form the loop using the portion of the suture.
 19. The suturing system of claim 11, the stitch looper rotates at least half a rotation to form the loop.
 20. The suturing system of claim 11, wherein the stitch looper includes two or more tines. 